HIV InfectionPhase 2NCT00121017
A Study Exploring an Induction-Maintenance Kaletra-Based Therapy Versus a Sustiva-Based Regimen in Previously Non-Treated, HIV-1/HCV Co-Infected Subjects
A Phase 2 study testing Kaletra (lopinavir/ritonavir), Sustiva (efavirenz) and Truvada (emtricitabine/tenofovir disoproxil fumarate) in people with HIV Infection and Hepatitis C, run by Abbott.
Trial summary
The purpose of this study is to determine whether a simplified lopinavir/ritonavir-based therapy will continue to keep the viral load at very low levels after initial treatment with a combination of Kaletra (lopinavir/ritonavir) plus tenofovir and emtricitabine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection, Hepatitis C
- What is being tested?
- Kaletra (lopinavir/ritonavir), Sustiva (efavirenz) and Truvada (emtricitabine/tenofovir disoproxil fumarate)
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is at least 18 years of age.
- Subject's plasma HIV-1 RNA is >1000 copies/mL at screening and in the investigator's opinion, the subject requires antiretroviral therapy.
- Subject is naive to antiretroviral therapy or has received <7 days total of any antiretroviral therapy >30 days prior to study drug administration.
- Subject has chronic HCV based on detectable plasma HCV RNA level (>600 IU/mL) at screening.
- Subject is not currently undergoing treatment of HCV infection and does not plan to initiate HCV treatment for the duration of this study.
- If female, the results of a urine pregnancy test performed at screening and on Day-1/Baseline are both negative.
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- If female, subject is either not of childbearing potential, defined as postmenopausal for at least one year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control: condoms, sponge, foams, jellies, diaphragm or intrauterine device, a vasectomized partner or total abstinence from sexual intercourse.
- Subject is not breastfeeding.
- Subject's vital signs, physical examination and laboratory results do not exhibit evidence of acute illness.
- Subject agrees not to take any drugs during the study, including over-the-counter medicines, vitamins, mineral supplements, herbal preparations, alcohol or recreational drugs without the knowledge and permission of the investigator.
- Subject has not been treated for an active AIDS-defining opportunistic infection within 30 days of initiating study drug.
- Subject has voluntarily signed and dated an informed consent from, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent must be signed before any study-specific procedures are performed.
Who cannot join
- Subject has a history of an allergic reaction or significant sensitivity to lopinavir, ritonavir, tenofovir, emtricitabine, lamivudine, and efavirenz or to any inert materials contained in the study drug formulations.
- Subject has a significant history of cardiac, renal, neurologic, psychiatric, oncologic or metabolic disease that would, in the opinion of the investigator, adversely affect his/her participation in this study.
- Subject has chronic hepatic disease of any etiology other than HCV infection (including hemochromatosis, autoimmune hepatitis, Wilson's Disease, and hepatocellular carcinoma).
- Subject has a liver biopsy result consistent with advanced chronic cirrhosis or a Child Pugh Score of "C".
- Subject is currently taking or will require any drugs that are contraindicated or have significant pharmacokinetic interactions with study drugs during the course of the study. For complete information refer to the most current product label for locally approved prescribing information for lopinavir/ritonavir (Kaletra), efavirenz (Sustiva), tenofovir disoproxil fumarate (Viread), emtricitabine (Emtriva), co-formulated emtricitabine/tenofovir disoproxil fumarate (Truvada) and lamivudine (Epivir).
- Subject has ongoing history of drug and/or alcohol abuse or psychiatric illness that in the investigator's opinion could preclude compliance with the protocol.
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- Subject has received any investigational drug or vaccine within 30 days prior to study drug administration.
- The screening HIV-1 genotype resistance report suggests resistance or possible resistance to the study RTI(s) or lopinavir/ritonavir; Evidence of possible resistance to efavirenz; Presence of one of the following mutations: RT L1001, K103N, V106A or M, V108I, Y181C or I, Y188L, G190A or S, P225H, M230L; Evidence of possible resistance to emtricitabine or lamivudine; Presence of one of the following mutations: RTm184V or I; Evidence of possible resistance to tenofovir; Presence of RT K65R or insertion at codon 69, or Presence of 2 or more of the following mutations: RTm41L, D67N, K70R, L210W; any change at T215, K219Q or evidence of possible resistance to lopinavir/ritonavir; Presence of one or more of the following mutations: protease I47V or A, G48V, I50V, V82A or F or T or S, I84V, 190M or Presence of 3 or more of the following mutations: protease L10F or I or R or V, K20M or R, L24I, V32I, L33F, M36I, M46I or L, F53L; any change at I54, A71V or T, G73S.
- Screening laboratory analyses show any of the following abnormal laboratory results: Presence of hepatitis B surface antigen (HBsAg) or anti-HBcAB (Total Ig, Total Bilirubin >/= 2.5x upper limit of normal (ULN), Hemoglobin <8.0 g/dL, Absolute neutrophil count < 750 cells/uL, Platelet count < 50,000/mL, ALT (SGPT) or AST (SGOT) > 5.0x ULN, Creatinine > 1.5x ULN, Calculated creatinine clearance < 50 mL/min, PT > 3.0 seconds prolonged from the ULN.
- For any reason, subject is considered by the investigator to be an unsuitable candidate to participate in the study.
About this study
Official title: A Randomized, Open-Label Study Assessing Safety, Tolerability and Efficacy of an Induction-Maintenance Treatment Strategy Including Lopinavir/Ritonavir Plus Tenofovir Disoproxil Fumarate and Emtricitabine Versus Efavirenz Plus Tenofovir Disoproxil Fumarate and Emtricitabine in Antiviral-naïve HIV-1/HCV Co-Infected Subjects
The purpose of this study is to determine whether a simplified lopinavir/ritonavir-based therapy will continue to keep the viral load at very low levels after initial treatment with a combination of Kaletra (lopinavir/ritonavir) plus tenofovir and emtricitabine.
- Conditions
- HIV Infection, Hepatitis C
- Being tested
- Kaletra (lopinavir/ritonavir), Sustiva (efavirenz), Truvada (emtricitabine/tenofovir disoproxil fumarate)
- Keywords
- HCV Infection, Treatment Naive
- Medical subject headings
- HIV Infections, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kaletra (lopinavir/ritonavir)Drug
Sustiva (efavirenz)Drug
Truvada (emtricitabine/tenofovir disoproxil fumarate)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with a plasma HIV-1 RNA level below 50 copies/mL at Week 96.
Secondary outcomes (3)
Vital signs
Physical examinations
Clinical laboratory tests
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Medical Information, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00121017
- Sponsor's protocol ID
- M05-731
- Status last verified
- Jul 2006
- First submitted
- 14 Jul 2005
- Last updated
- 27 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label Study Assessing Safety, Tolerability and Efficacy of an Induction-Maintenance Treatment Strategy Including Lopinavir/Ritonavir Plus Tenofovir Disoproxil Fumarate and Emtricitabine Versus Efavirenz Plus Tenofovir Disoproxil Fumarate and Emtricitabine in Antiviral-naïve HIV-1/HCV Co-Infected Subjects
- ClinicalTrials.gov ID
- NCT00121017
- Acronym / sponsor ID
- M05-731
- Conditions
- HIV Infection, Hepatitis C
- Keywords
- HCV Infection, Treatment Naive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 200 participants
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- First posted
- 21 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a simplified lopinavir/ritonavir-based therapy will continue to keep the viral load at very low levels after initial treatment with a combination of Kaletra (lopinavir/ritonavir) plus tenofovir and emtricitabine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subject is at least 18 years of age.
- Subject's plasma HIV-1 RNA is >1000 copies/mL at screening and in the investigator's opinion, the subject requires antiretroviral therapy.
- Subject is naive to antiretroviral therapy or has received <7 days total of any antiretroviral therapy >30 days prior to study drug administration.
- Subject has chronic HCV based on detectable plasma HCV RNA level (>600 IU/mL) at screening.
- Subject is not currently undergoing treatment of HCV infection and does not plan to initiate HCV treatment for the duration of this study.
Key exclusion criteria (10 listed)
- Subject has a history of an allergic reaction or significant sensitivity to lopinavir, ritonavir, tenofovir, emtricitabine, lamivudine, and efavirenz or to any inert materials contained in the study drug formulations.
- Subject has a significant history of cardiac, renal, neurologic, psychiatric, oncologic or metabolic disease that would, in the opinion of the investigator, adversely affect his/her participation in this study.
- Subject has chronic hepatic disease of any etiology other than HCV infection (including hemochromatosis, autoimmune hepatitis, Wilson's Disease, and hepatocellular carcinoma).
- Subject has a liver biopsy result consistent with advanced chronic cirrhosis or a Child Pugh Score of "C".
- Subject is currently taking or will require any drugs that are contraindicated or have significant pharmacokinetic interactions with study drugs during the course of the study. For complete information refer to the most current product label for locally approved prescribing information for lopinavir/ritonavir (Kaletra), efavirenz (Sustiva), tenofovir disoproxil fumarate (Viread), emtricitabine (Emtriva), co-formulated emtricitabine/tenofovir disoproxil fumarate (Truvada) and lamivudine (Epivir).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kaletra (lopinavir/ritonavir) | Drug | – |
| Sustiva (efavirenz) | Drug | – |
| Truvada (emtricitabine/tenofovir disoproxil fumarate) | Drug | – |
Primary outcome
The proportion of subjects with a plasma HIV-1 RNA level below 50 copies/mL at Week 96.
3 secondary outcomes
Vital signs
Physical examinations
Clinical laboratory tests
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Medical Information study director
Abbott
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Kaletra (lopinavir/ritonavir), Sustiva (efavirenz) and Truvada (emtricitabine/tenofovir disoproxil fumarate) in people with HIV Infection and Hepatitis C, run by Abbott.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects with a plasma HIV-1 RNA level below 50 copies/mL at Week 96.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2006.